Safety Physician

1-2 years

Not Disclosed

Remote

10 Feb. 11, 2025

Job Description

Job Type: Full Time Education: MD/MBBS/DO Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Here's the rewritten description along with a unique slug:

Safety Physician – Pharmacovigilance & Medical Review

Updated: January 30, 2025
Location: India (Home-Based)
Job ID: 25001289

About Syneos Health

Syneos Health® is a globally recognized biopharmaceutical solutions provider dedicated to accelerating success for clients. By integrating clinical development, medical affairs, and commercial expertise, we deliver transformative insights and outcomes that address modern healthcare challenges.

Our Clinical Development approach places the patient and client at the heart of everything we do. Through collaboration and innovation, we continuously refine our processes to enhance efficiency, making Syneos Health both a great place to work and a trusted partner in the industry.

Join a team of 29,000 professionals across 110 countries, working together to drive meaningful change in the healthcare landscape.

Why Syneos Health?

Commitment to career growth and professional development.
Supportive leadership and an engaging work environment.
A culture that values diversity, authenticity, and inclusivity.
Competitive total rewards program recognizing your contributions.

Role Overview – Safety Physician

As a Safety Physician, you will play a pivotal role in pharmacovigilance, ensuring the highest standards of medical review, regulatory compliance, and risk management for investigational and marketed products.

Key Responsibilities

Conduct medical reviews of adverse event reports for investigational and marketed drugs.
Ensure compliance with regulatory requirements and company SOPs in evaluating, reporting, and monitoring drug safety.
Collaborate with Safety and Pharmacovigilance (SPVG) colleagues to maintain consistency in adverse event assessments.
Identify, communicate, and manage potential drug safety concerns.
Engage with client safety and medical personnel as needed.
Provide medical insights and review for aggregate safety reports (e.g., PSURs, PADERs, annual safety reports).
Stay updated on clinical developments and industry regulations.
Offer mentorship and training to internal safety staff.
Participate in compliance-related activities to uphold corporate and departmental policies.
Perform additional duties as assigned by management.

Qualifications & Skills Required

Education: M.D., MBBS, or D.O. degree.
Clinical Experience: Minimum of 1–2 years in clinical practice (accredited residency completed).
Industry Experience: At least 1 year in pharmacovigilance within the pharmaceutical, biotech, or medical device industry (preferred).
Regulatory Knowledge: Familiarity with global pharmacovigilance regulations and processes.
Technical Proficiency: Experience with MedDRA, WHO-DRL, safety databases (e.g., ARGUS), and Microsoft Office Suite.
Communication Skills: Strong verbal and written communication in English; additional language skills for case processing are a plus.
Interpersonal Skills: Ability to inform, influence, and collaborate effectively within cross-functional teams.
Flexibility: Willingness to travel occasionally (up to 10%).

Why Join Us?

At Syneos Health, your work has a real impact. In the last five years, we have contributed to 94% of all FDA-approved novel drugs, 95% of EMA-authorized products, and over 200 clinical studies across 73,000 sites with 675,000+ trial patients.

Be part of a company that challenges the status quo and transforms lives.

Learn more about Syneos Health

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Safety Physician

Job Description

Safety Physician – Pharmacovigilance & Medical Review

About Syneos Health

Role Overview – Safety Physician

Key Responsibilities

Qualifications & Skills Required

Why Join Us?

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